MAUDE Adverse Event Report: MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 15CM, NITINOL; PROBE, RADIOFREQUENCY LESION

Model Number	RF-NE-15
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
During testing smoke was emitting from the tip of the electrode.There were no adverse consequences to a user or patient.
Additional Manufacturer Narrative
One nitinol reusable rf thermocouple electrode was received for evaluation.The electrode did not display a temperature increase when exposed to heat.Electrical testing revealed a short circuit within the hub, consistent with the smoke emitted from the probe during testing on the grounding pad.The device was manufactured according to specifications as supported by the receiving inspection results.The root cause of the short circuit and the subsequent smoke could not be conclusively determined.

• Brand Name: REUSABLE ELECTRODE, 15CM, NITINOL
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): MINTA MEDICAL LIMITED; caddick road; merseyside knowsley L34 9 HP; UK L34 9HP
• MDR Report Key: 7996084
• Report Number: 3004617090-2018-00009
• Device Sequence Number: 11109137
• Product Code: GXI
• UDI-Device Identifier: 05415067025197
• UDI-Public: 05415067025197
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K090608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RF-NE-15
• Device Lot Number: M12801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1